title: Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): an alternative to autogenous bone graft.
abstract: BACKGROUND
  Joint arthrodesis employing autogenous bone graft (autograft) remains a mainstay in the treatment of many foot and ankle problems. However, graft harvest can lead to perioperative morbidity and increased cost. We tested the hypothesis that purified recombinant human platelet-derived growth factor-BB (rhPDGF-BB) homodimer combined with an osteoconductive matrix (beta-tricalcium phosphate [β-TCP]) would be a safe and effective alternative to autograft.
  
  
  METHODS
  A total of 434 patients were enrolled in thirty-seven clinical sites across North America in a prospective, randomized (2:1), controlled, non-inferiority clinical trial to compare the safety and efficacy of the combination rhPDGF-BB and β-TCP with those of autograft in patients requiring hindfoot or ankle arthrodesis. Radiographic, clinical, functional, and quality-of-life end points were assessed through fifty-two weeks postoperatively.
  
  
  RESULTS
  Two hundred and sixty patients (394 joints) underwent arthrodesis with use of rhPDGF-BB/β-TCP. One hundred and thirty-seven patients (203 joints) underwent arthrodesis with use of autograft. With regard to the primary end point, 159 patients (61.2% [262 joints (66.5%)]) in the rhPDGF-BB/β-TCP group and eighty-five patients (62.0% [127 joints (62.6%)]) in the autograft group were fused as determined by computed tomography at six months (p < 0.05). Clinically, 224 patients (86.2%) [348 joints (88.3%)]) in the rhPDGF-BB/β-TCP group were considered healed at fifty-two weeks, compared with 120 patients (87.6% [177 joints (87.2%)] in the autograft group (p = 0.008). Overall, fourteen of sixteen secondary end points at twenty-four weeks and fifteen of sixteen secondary end points at fifty-two weeks demonstrated statistical non-inferiority between the groups, and patients in the rhPDGF-BB/β-TCP group were found to have less pain and an improved safety profile.
  
  
  CONCLUSIONS
  In patients requiring hindfoot or ankle arthrodesis, treatment with rhPDGF-BB/β-TCP resulted in comparable fusion rates, less pain, and fewer side effects as compared with treatment with autograft.
authors.affiliation: Department of Orthopaedic Surgery, The Warren Alpert School of Medicine at Brown University, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, USA. christopher_digiovanni@brown.edu
authors.forename: Christopher W
authors.initials: CW
authors.lastname: DiGiovanni
authors.forename: Sheldon S
authors.initials: SS
authors.lastname: Lin
authors.forename: Judith F
authors.initials: JF
authors.lastname: Baumhauer
authors.forename: Timothy
authors.initials: T
authors.lastname: Daniels
authors.forename: Alastair
authors.initials: A
authors.lastname: Younger
authors.forename: Mark
authors.initials: M
authors.lastname: Glazebrook
authors.forename: John
authors.initials: J
authors.lastname: Anderson
authors.forename: Robert
authors.initials: R
authors.lastname: Anderson
authors.forename: Peter
authors.initials: P
authors.lastname: Evangelista
authors.forename: Samuel E
authors.initials: SE
authors.lastname: Lynch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D043925:Angiogenesis Inducing Agents / Q000627:therapeutic use*; D000843:Ankle Joint / Q000601:surgery*; D001174:Arthrodesis / Q000379:methods; D000077214:Becaplermin; D001672:Biocompatible Materials / Q000627:therapeutic use*; D016025:Bone Transplantation; D002130:Calcium Phosphates / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D020574:Proto-Oncogene Proteins c-sis / Q000627:therapeutic use*
chemical_list: D043925:Angiogenesis Inducing Agents; D001672:Biocompatible Materials; D002130:Calcium Phosphates; D020574:Proto-Oncogene Proteins c-sis; C485817:beta-tricalcium phosphate; D000077214:Becaplermin